Assembly with Imaging Electronics

ABSTRACT

A catheter with an imaging assembly is disclosed. The catheter is used with a console for viewing and/or storing images obtained from the catheter. The catheter may be a feeding tube assembly. The imaging assembly on the feeding tube assembly allows a user to confirm placement of the feeding tube assembly in the patient&#39;s alimentary canal.

The present application claims priority to U.S. Provisional ApplicationSer. Nos. 61/482,080, filed May 3, 2011, and 61/380,985, filed Sep. 8,2010, each of which is incorporated herein by reference in its entiretyfor all purposes.

BACKGROUND

Several medical procedures involve positioning a catheter, such as afeeding tube or endoscope, within a patient through the patient's nose,mouth, or other opening. In many procedures, accurately positioning thecatheter is crucial to the success of the procedure and/or to the safetyof the patient. For example, a nasogastric (NG) feeding tube may beinserted through the nose, past the throat, and down into the stomach,or past the stomach into the small bowels of the patient to deliver foodto the patient via the tube. If the feeding tube is mistakenlypositioned in the patient's lung, the feeding solution would bedelivered to the patient's lung causing critical and possibly fatalresults.

Accordingly, x-ray imaging devices and procedures have been used toconfirm accurate positioning of a feeding tube, or other type ofcatheter, within a patient. Specifically, x-ray images are taken of thepatient after a feeding tube has been initially positioned within thepatient. The x-ray images are examined to determine whether the feedingtube was properly positioned or whether re-positioning is necessary. Thex-ray imaging procedure is repeated until feeding tube has been properlypositioned.

These x-ray imaging procedures are generally expensive and timeconsuming. Additionally, a patient often uses a feeding tube for asubstantial length of time. Thus, the x-ray imaging procedures must berepeated periodically to ensure that the feeding tube has not moved(i.e., migrated).

SUMMARY

In one aspect, an imaging catheter system generally comprises an imagingcatheter and a console. The imaging catheter includes an elongate bodyhaving opposite first and second ends. An imaging assembly is at thefirst end of the elongate body and includes an imaging device forgenerating imaging signals indicative of images of anatomy of a subject.The imaging assembly is adapted to transmit the imaging signalsgenerated by the imaging device. An electronic memory component has apredefined identifier of the imaging catheter written thereon. Theconsole includes a display. The console is configured for receiving theimaging signals from the imaging assembly and displaying imagesgenerated from the imaging signals on the display. The console isconfigured to read the predefined identifier from the electronic memorycomponent.

In another aspect, a feeding tube assembly generally comprises aflexible feeding tube having opposite first and second longitudinalends, a longitudinal axis extending between the first and secondlongitudinal ends, and a feeding passage defined therein extending alongthe longitudinal axis between the first and second longitudinal ends. Aninlet adaptor is adjacent the second longitudinal end of the tube influid communication with the feeding passage. The inlet adaptor isconfigured for fluid connection to a source of enteral feeding liquid tofluidly connect the source of enteral feeding liquid to the feedingpassage. An imaging assembly includes an imaging device. The imagingassembly is configured for generating and transmitting imaging signalsindicative of images of the alimentary canal of a subject. The imagingassembly is secured to the tube adjacent the first longitudinal end ofthe tube and is sealed from the feeding passage to inhibit enteralfeeding liquid in the feeding passage from entering the imagingassembly. A feeding outlet is proximate the imaging assembly and influid communication with the feeding passage for delivering enteralfeeding liquid to the subject. A console connector is communicativelyconnected to the imaging assembly, the console connector configured foruse in communicatively connecting the imaging assembly to a console toallow transmission of the imaging signals to the console.

In yet another aspect, a feeding tube system generally comprises afeeding tube assembly and a console. The feeding tube assembly includesa feeding tube having opposite first and second ends and a feedingpassage fluidly connecting the first and second ends. An inlet adaptoris adjacent the second end of the tube in fluid communication with thefeeding passage. The inlet adaptor is configured for fluid connection toa source of enteral feeding liquid to fluidly connect the source ofenteral feeding liquid to the feeding passage. An imaging assemblyincludes an imaging device and is configured for generating andtransmitting imaging signals indicative of images of the alimentarycanal of a subject. The imaging assembly is secured to the tube adjacentthe first end of the tube and is sealed from the feeding passage toinhibit enteral feeding liquid in the feeding passage from entering theimaging assembly. A feeding outlet is intermediate the inlet adaptor andthe imaging assembly and in fluid communication with the feeding passagefor delivering enteral feeding liquid to the subject. The consoleincludes a display, and is operatively coupled to the feeding tubeassembly and configured for receiving imaging signals transmitted by theimaging assembly and displaying images generated from the imagingsignals on the display.

In another embodiment, a feeding tube assembly generally comprises aflexible feeding tube having opposite first and second longitudinalends, and a feeding passage defined therein extending between the firstand second ends. An inlet adaptor is adjacent the second longitudinalend of the tube in fluid communication with the feeding passage. Theinlet adaptor is configured for fluid connection to a source of enteralfeeding liquid. An imaging assembly includes an imaging device forgenerating imaging signals indicative of images of the alimentary canalof a subject. The imaging assembly is secured to the feeding tubeadjacent the first end of the tube and is fluidly isolated from feedingpassage. A console connector is secured to the feeding tube proximatethe inlet adaptor. The console connector is communicatively connected tothe imaging assembly, and configured for use in connecting to theimaging assembly to a console to allow transmission of the imagingsignals to the console.

In yet another embodiment, an imaging catheter assembly generallycomprises an elongate body having a first body end, and an opposite asecond body end; and an imaging assembly secured to the first body end.The imaging assembly has a first imaging assembly end remote from thefirst body end, a second imaging assembly end adjacent the first bodyend, and an imaging assembly longitudinal axis extending between thefirst and second imaging assembly ends. The imaging assembly includes arigid-flex circuit having an electronic component mounting portionextending along the imaging assembly longitudinal axis from adjacent thesecond imaging assembly end toward the first imaging assembly end, and acamera mounting portion adjacent the first imaging assembly end andextending generally transverse to the imaging assembly. The electroniccomponent mounting portion includes longitudinally spaced first andsecond rigid sections and a first flexible section disposed between thefirst and second rigid sections. A first electronic component is mountedon the first rigid section of the electronic component mounting portion.A second electronic component is mounted on the second rigid section ofthe electronic component mounting portion. A camera is mounted on thecamera mounting portion, and the camera is communicatively connected tothe first and second electronic components. The rigid-flex circuit isdisposed in a housing. The housing circumferentially surrounds at leasta portion of the rigid-flex circuit. The first flexible section of theelectronic component mounting portion is free from electronic componentsmounted thereon such that the rigid-flex circuit is capable of bendingat the first flexible section.

In another aspect, an imaging catheter system for use in performing amedical procedure generally comprises an imaging catheter and a console.The imaging catheter includes an elongate body having opposite first andsecond ends. An imaging assembly at the first end of the body is adaptedto be inserted into a subject. The imaging assembly includes an imagingdevice for generating imaging signals representative of images ofanatomy of the subject when the imaging assembly is inserted in thesubject. The imaging assembly is adapted to transmit the imaging signalsgenerated by the imaging device. The imaging catheter includes anelectronic memory component. The console including a display, and isconfigured for receiving the imaging signals transmitted by the imagingassembly and displaying images generated from the imaging signals on thedisplay. The console is configured to write data to the electronicmemory component during use of the imaging catheter.

In another aspect, an imaging catheter system for use in performing amedical procedure generally comprises an imaging catheter and a console.The imaging catheter includes an elongate body having opposite first andsecond ends. An imaging assembly at the first end of the body is adaptedto be inserted into a subject. The imaging assembly includes an imagingdevice for generating imaging signals representative of images ofanatomy of the subject when the imaging assembly is inserted in thesubject. The imaging assembly is adapted to transmit the imaging signalsgenerated by the imaging device. The console includes a display. Theconsole is configured for receiving the imaging signals transmitted bythe imaging assembly and displaying images generated from the imagingsignals on the display. The console is configured to simultaneouslypresent an image previously received by the console from the imagingassembly and a current image from image data currently being received bythe console from the imaging assembly.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

Other features will be in part apparent and in part pointed outhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration showing a perspective view of animaging feeding tube assembly, in accordance with one or more aspects ofthe invention;

FIG. 2 is schematic illustration showing a perspective view of thefeeding tube assembly in FIG. 1, in accordance with one or more aspectsof the invention;

FIG. 3 is a schematic illustration showing a side, elevational view ofan imaging feeding tube system, including the imaging feeding tubeassembly in FIG. 1, and interface cable, and a console, in accordancewith one or more aspects of the invention;

FIG. 4A is schematic illustration showing a perspective view of aconsole connector of the feeding tube assembly in FIG. 1, showinginternal components and including feeding tube segments of a feedingtube, in accordance with one or more aspects of the invention;

FIG. 4B is a schematic illustration showing another embodiment of aninlet adaptor for the imaging feeding tube assembly, in accordance withone or more aspects of the invention;

FIG. 5 is a schematic illustration showing an enlarged, fragmentary,perspective view of a distal end portion of the feeding tube assembly inFIG. 1, including an exploded imaging assembly, an imaging assemblyconnector, and a portion of the feeding tube, in accordance with one ormore aspects of the invention;

FIG. 6 is a schematic illustration showing an enlarged cross sectionview of the feeding tube of the feeding tube assembly in FIG. 1, inaccordance with one or more aspects of the invention;

FIG. 7 is a schematic illustration showing a top perspective view of aflex circuit assembly of the imaging assembly in FIG. 5, in a foldedconfiguration, in accordance with one or more aspects of the invention;

FIG. 8 is a schematic illustration showing a bottom perspective view ofthe flex circuit assembly of the imaging assembly in FIG. 4, in thefolded configuration, in accordance with one or more aspects of theinvention;

FIG. 9 is a schematic illustration showing a fragmentary view of theimaging assembly in FIG. 5, in accordance with one or more aspects ofthe invention;

FIG. 10 is a schematic illustration showing a perspective view of a capof the imaging assembly in FIG. 5, in accordance with one or moreaspects of the invention;

FIG. 11 is a block diagram of the flex circuit assembly in FIG. 7, inaccordance with one or more aspects of the invention;

FIGS. 12 and 13 are circuit schematic illustrations of the flex circuitembodiment in FIG. 11, in accordance with one or more aspects of theinvention;

FIG. 14 is a schematic illustration showing a top plan view of the flexcircuit assembly of the imaging assembly in FIG. 7, in an unfoldedconfiguration, in accordance with one or more aspects of the invention;

FIG. 15 is a schematic illustration showing a top view of a firstsubstrate of the flex circuit assembly in FIG. 14, in accordance withone or more aspects of the invention;

FIG. 16 is a block diagram of the flex circuit assembly, in accordancewith one or more aspects of the invention;

FIG. 17 is a block diagram of the flex circuit assembly, in accordancewith one or more aspects of the invention;

FIG. 18 is a block diagram of an exemplary feeding tube system, inaccordance with one or more aspects of the invention;

FIG. 19 is a flow diagram showing an exemplary graphical user interfacescreen flow, in accordance with one or more aspects of the invention;

FIGS. 20-31 are schematic illustrations showing exemplary graphical userinterface screens displayable by a console, in accordance with one ormore aspects of the invention;

FIG. 32A is a schematic illustration showing a perspective view of animaging feeding tube assembly, in accordance with one or more aspects ofthe invention;

FIG. 32B is a schematic illustration showing an exploded perspective ofthe imaging feeding tube assembly in FIG. 32A, in accordance with one ormore aspects of the invention;

FIG. 33 is a schematic illustration showing a cross-sectional view of afeeding tube of the imaging feeding tube assembly in FIG. 32A, inaccordance with one or more aspects of the invention;

FIG. 34 is a schematic illustration showing an exploded perspective viewof an imaging assembly of the imaging feeding tube assembly in FIG. 32A,in accordance with one or more aspects of the invention;

FIG. 35 is a schematic illustration showing a perspective view of arigid-flex circuit assembly, in accordance with one or more aspects ofthe invention;

FIG. 36 is a schematic illustration showing a top plan view of arigid-flex circuit, in accordance with one or more aspects of theinvention;

FIG. 37 is a schematic illustration showing a side, elevational view ofa rigid-flex circuit, in accordance with one or more aspects of theinvention;

FIG. 38 is a schematic illustration showing a perspective view of animaging assembly connector of the imaging feeding tube assembly in FIG.32A, in accordance with one or more aspects of the invention;

FIG. 39 is a schematic illustration showing a perspective view of theimaging assembly in FIG. 34, with a housing removed therefrom to showinternal components, in accordance with one or more aspects of theinvention;

FIG. 40 is a schematic illustration showing a longitudinal section viewof the housing of the imaging assembly in FIG. 34, in accordance withone or more aspects of the invention;

FIG. 41 is a schematic illustration showing an imaging assembly, inaccordance with one or more aspects of the invention;

FIG. 42 is a schematic illustration showing a cross-sectional view of aconsole connector of the imaging feeding tube assembly, in accordancewith one or more aspects of the invention;

FIG. 43 is a schematic illustration showing an interface cable, inaccordance with one or more aspects of the invention;

FIG. 44 is a schematic illustration showing a perspective view of a flexcircuit assembly, with a flex circuit in a folded configuration, inaccordance with one or more aspects of the invention; and

FIG. 45 is a schematic illustration showing a perspective view of theflex circuit in FIG. 44 in an unfolded or flat configuration, inaccordance with one or more aspects of the invention.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION

Referring now to the drawings, and in particular to FIGS. 1-3, animaging catheter is generally indicated at 10. As disclosed herein, theimaging catheter can be a medical device that is configured forinsertion into a subject (e.g., a human or a non-human subject) andconfigured to provide images (e.g., digital video) of anatomy of thesubject as the medical device is inserted into the subject and/or afterthe medical device is positioned in the subject. In the illustratedembodiment, the imaging catheter is configured as a feeding tubeassembly 10 and exemplarily illustrated as a nasogastric feeding tubeassembly. In general, the illustrated nasogastric feeding tube assembly10 can be configured to provide digital images of an alimentary canal,or a portion(s) thereof, of the subject as the feeding tube assembly isinserted into the subject and after the feeding tube assembly ispositioned in the subject to facilitate confirmation of proper placementof the feeding tube assembly in the subject. The nasogastric feedingtube assembly 10 can be also configured to deliver liquid nutrients intothe alimentary canal of the subject by enteral feeding, such as after auser (e.g., medical practitioner) confirms proper placement of thefeeding tube assembly in the subject, by viewing the acquired digitalimages from the imaging feeding tube assembly. It is understood that theimaging catheter 10 may be configured as a different type of feedingtube, such as a gastric feeding tube, or a jejunostomy feeding tube, ormay be configured as a different type of medical device, such as anendoscope, or a heart catheter (e.g., balloon catheter or other type ofheart catheter).

The illustrated feeding tube assembly 10 generally includes an elongate,generally flexible body in the form of a feeding tube, generallyindicated at 12, having a longitudinal axis A (FIG. 6), an open firstlongitudinal end (i.e., a distal end) and an open second longitudinalend (i.e., a proximal end). A feeding passage 14 (FIGS. 4-6), defined byan interior surface of the feeding tube 12, extends longitudinallybetween the longitudinal ends of the tube for delivering nutrients(e.g., in the form of an enteral feeding solution) to the subject. Inother embodiments—such as catheters that are not feeding tubes—theelongate body may have other configurations, and may not have alongitudinal passage for delivering fluids to the patient. An inletadapter, generally indicated at 16, for delivering liquid nutrients intothe feeding passage 14 is attached to the second end of the tube, and animaging assembly, generally indicated at 18, for generating andtransmitting real time images (e.g., video) of the alimentary canal ofthe patient during and/or following intubation is attached to the firstend of the tube 12 by an imaging assembly connector, generally indicatedat 20. As used herein with the point of reference being the feedingsource, the inlet adaptor 16 defines the proximal end of the feedingtube assembly 10, and the imaging assembly 18 defines the distal end.The feeding tube assembly 10 also can include a console connector,generally indicated at 22, in communication with the imaging assembly18, to provide communication between the imaging assembly and a console23 (FIG. 3), on which the images obtained by the imaging assembly 18 maybe displayed, as described in detail herein. In the illustratedembodiment, the feeding tube assembly 10, the console 23, and aninterface cable 242, which communicatively connects the feeding tubeassembly to the console, together constitutes an imaging cathetersystem, and more specifically, an imaging feeding tube system.

Referring to FIGS. 1-4, the exemplarily illustrated feeding tube 12comprises two tube segments: a first tube segment 12 a extending betweenthe imaging assembly connector 20 and the console connector 22, and asecond tube segment 12 b extending between the console connector and theinlet adaptor 16. As disclosed in more detail below, the first andsecond tube segments 12 a, 12 b can be secured to the console connector22 in such a way that the first and second tube segments are in fluidcommunication with each other to at least partially define the feedingpassage 14. In other embodiments of the invention, the tube 12 may beformed as an integral, one-piece component.

The tube 12 may comprise indicia such as graduations (not shown) thatshow or providing a relative indication of insertion depth to facilitateproper intubation. In one example, the tube 12 may have a length betweenabout 36 inches and about 55 inches, although it may be of other lengthswithout departing from the scope of the invention.

As shown in FIG. 6, the first tube segment 12 a typically includes oneor more electrical conductors 24 (broadly, a signal-transmittingcomponent) typically disposed in the tube wall of the first tubesegment. The second tube segment 12 b may be free from such electricalconductors. The electrical conductors 24 of the first tube segment 12 arun longitudinally along the first tube segment, such as along orparallel a longitudinal axis of the feeding passage 14. At least some ofthe electrical conductors 24 can be configured to transmit imagingsignals between the imaging assembly 18 and the console 23, such asthrough the console connector 22 and the interface cable 242. Otherelectrical conductors 24 may be configured to transmit power from theconsole 23 to the imaging assembly 18, and provide a ground. Still otherelectrical conductors 24 may be configured to provide othercommunication including, but not limited to, two-way communication,between the console 23 and the imaging assembly 18. The first tubesegment 12 a may include a different type of a signal-transmittingcomponent, such as fiber-optic cables or other signal-transmittingcomponents, to effect transmission of signals between the imagingassembly 18 and the console connector 22. In one or more embodiments ofthe invention, at least one of the electrical conductors 24 isconfigured to supply power from a power supply, which can be the console23, to the imaging assembly 18, although other ways of powering theimaging assembly, including the imaging assembly having its own sourceof power, do not depart from the scope of the present invention.

As exemplarily illustrated, the electrical conductors 24 can be disposedwithin a conductor passage 26 of the feeding tube 12 so that theconductors are physically separated or at least fluidly isolated fromthe feeding passage 14 to inhibit or reduce the likelihood of feedingsolution in the feeding passage from contacting the conductors. As shownin FIG. 6, the interior surface defining a portion of the feedingpassage 14 in the first tube segment 12 a has a generally circular crosssection having an arcuate portion 28 extending inwardly and runninglongitudinally along a lengthwise dimension of the feeding tube assemblyor segment. The electrical conductors 24 can be disposed within the tubewall of the first tube segment 12 a between the arcuate portion 28 ofthe interior surface and the exterior surface of the tube segment whichprovides a configuration that allows physical separation between theelectrical conductors 24 and the enteral feeding solution in the feedingpassage 14, as disclosed above, and can maximize the area or volume ofthe feeding passage. A longitudinal axis A passes through the feedingpassage 14. As such, this configuration promotes the flow of fluid inthe feeding passage 14 and reduces the likelihood of occlusions in thefeeding passage. A substantially uniform wall thickness around passage14, as shown in FIG. 5, can decrease the amount of material entrapmentthat may occur, or at least can reduce the likelihood of formation ofocclusions. It is understood that the first tube segment 12 a may be ofother configurations without departing from the scope of the presentinvention.

The feeding tube 12, including, for example, the first and second tubesegments 12 a, 12 b, may be formed from a thermoplastic polyurethanepolymer, such as but not limited to, an aromatic, polyether-basedthermoplastic polyurethane, and a radiopaque substance, such as barium.The first and second tube segments 12 a, 12 b may be formed by anextrusion process. The tube 12 may be formed from other materials andmay be formed in other ways without departing from the scope of thepresent invention. In one non-limiting example, the electricalconductors 24 (or other signal-transmitting components) may beco-extruded with the first tube segment 12 a to embed the conductors inthe first tube segment. In another example, the conductors 24 (or othersignal-transmitting components) may be fed through the conductor passage26 after forming the first tube segment 12 a. Introducing any of the oneor more conductors 12 can be facilitated by, for example, internallypressurizing passage 26 with a fluid prior to insertion therein. Otherways of forming the first tube segment 12 a and/or the tube 12 do notdepart from the scope of the present invention.

Referring back further to FIGS. 1 and 2, the illustrated inlet adaptor16 typically includes first and second inlet ports 30, 32, respectively,in fluid communication with a single outlet port 34. The exemplarilyillustrated inlet adaptor 16 may be referred to as a Y-port. The firstinlet port 30 may be used for connection to a source of liquidnutrients, such as an enteral feeding solution. For example, a barbedconnector (not shown), in fluid communication with the source of anenteral feeding solution, may be inserted into the first inlet port 30and secured therein by a friction-fit. Thus an aspect of the presentinvention may involve configurations with the feeding fluid in fluidcommunication with the feeding tube assembly. An optional cap 35tethered on the inlet adaptor 16 can be removably receivable in thefirst inlet port 30 to close the inlet port when it is not being used.The second inlet port 32 may be used for connection to a source ofmedicine. Optional tethered first and second caps 36, 37, respectively,can be used to variably configure the second inlet port 32 as aconnection or port to various or different connectors typically usedwith various sources of medicine. For example, the first cap 36 can beremovably receivable in the second inlet port 32, providing a centralopening therethrough that is sized and shaped to mate with a cathetersyringe. The second cap 37 can be removably receivable in the centralopening in the first cap 36, thereby providing a central opening that issized and shaped to particularly mate with a tip of an oral syringe. Theinlet adaptor 16 may take on other shapes, sizes and configurations, ormay be entirely omitted, without departing from the scope of theinvention.

The inlet adaptor 16 can be secured to the second or proximal end of thetube 12 at an adaptor weld, generally indicated at 38, so that theoutlet port 34 of the adaptor 16 is in sealed fluid communication withthe feeding passage 14 of the feeding tube. The adaptor weld 38typically tapers distally from the adaptor 16 to the tube 12 so that theweld has a smooth, generally continuously decreasing diameter. It is tobe understood that the adaptor 16 may be secured to the tube 12 in otherways without departing from the scope of the invention. For example, theinlet adaptor 16 may be secured to the tube 12 by solvent bonding, orother securement techniques. The adaptor 16 may be composed of the samematerial as the feeding tube 12, or a blend of materials, or a differentbut compatible material. In one example, the adaptor 16 is composed ofblend of polyvinyl chloride and polyurethane elastomer. In anotherexample, the adaptor 16 is composed of an aromatic, polyether-basedthermoplastic polyurethane or DEHP-free PVC. The adaptor 16 may beformed from other types of materials within the scope of the invention.

Referring to FIGS. 1, 2, and 5, the imaging assembly connector 20 canhave a first end margin, such as a distal end margin, secured to theimaging assembly 18, and a second end margin, such as a proximal endmargin, secured to the first end margin of the first tube segment 12 a.The imaging assembly connector 20 typically defines a feeding outlet 40that is in fluid communication with the feeding passage 14 of the tube12. The feeding outlet 40 can comprise one or more openings extendinglaterally through a side of the imaging assembly connector 20 (only onesuch lateral opening is illustrated). In the illustrated embodiment, thefirst or distal end of the tube 12 is received and secured within theimaging assembly connector 20 at the second or proximal end of theimaging assembly connector to provide fluid communication between thefeeding passage 14 and the feeding outlet 40. The imaging assemblyconnector 20 can be closed adjacent the first or distal end to preventthe feeding solution in the feeding passage 14 from entering the imagingassembly 18. Thus, the imaging assembly 18 is typically sealed off fromand not in fluid communication with the feeding passage 14. Instead, thefeeding solution typically flows laterally out from the outlet 40relative to the feeding tube 12. When the feeding tube assembly 10 isdetermined to be appropriately positioned in a patient, feeding solutionor other desirable liquid fed into the inlet adaptor 16 can beintroduced through the feeding passage 14 of the tube 12, and outthrough the outlet 40 and into the subject's alimentary canal. Asillustrated in FIG. 5, the first end margin of the imaging assemblyconnector 20 can have a connection portion 42 shaped and sized to fit inthe imaging assembly 18. The imaging assembly connector 20 may be formedintegrally with the imaging assembly 18 or may be omitted, withoutdeparting from the scope of the present invention.

The electrical conductors 24 may be embedded or otherwise received inthe wall of the imaging assembly connector 20 so that the conductors aresealed from the feeding outlet 40 and the feeding passage 14 to inhibitfeeding solution from contacting the conductors. In one embodiment, theimaging assembly connector 20 may include two distinct parts that areassembled together. The first part may define the feeding outlet 40 thatreceives liquid from the tube 12, as described above, and a conductorpassage (not shown) that is separate and apart from the feeding passageoutlet. The second part may define the connection portion 42 and aconductor passage extending to a conductor passage in the first part tofacilitate connection of or carry the electrical conductors 24 betweenthe imaging assembly 18 and the tube 12. The imaging assembly connector20 may take on other shapes, sizes and configurations (or may beentirely omitted) without departing from the scope of the invention.Moreover, the imaging assembly 18 may be secured to the tube 12 in otherways without departing from the scope of the present invention.

In one example, the imaging assembly connector 20 may be injectionmolded onto the end of the feeding tube 12. The direct connection of theimaging assembly connector 20 to the feeding tube provides strain relieffor the electrical conductors 24 extending out of the end of the feedingtube 12 to the imaging assembly.

Referring to FIG. 5, the imaging assembly 18 can include a tubularhousing 50, a flexible circuit (“flex circuit”) assembly 60 disposedwithin the tubular housing, and a transparent or translucent cap 70secured to the tubular housing 50. Generally speaking a flex circuitincludes a deformable circuit element and components mounted on thedeformable circuit element. The deformable circuit element may be a flat(at least prior to being deformed) substrate that can be bent orotherwise deformed, and which also includes electrical conductors formaking electrical connection among various components that may bemounted on the substrate. The deformable circuit element may only bepartially deformable (e.g., only at discrete bend lines) within thescope of the present invention. Among other functions, the tubularhousing 50 can provide protection for the flex circuit assembly 60, andthe housing may be substantially waterproof to inhibit the ingress ofliquid into the imaging assembly 18. The tubular housing 50 has aninterior surface defining an axial passage 52 shaped and sized forhousing the flex circuit assembly 60 in a folded configuration. In oneembodiment, the tubular housing 50 is formed from a generally flexiblematerial that provides protection for the flex circuit assembly 60 andallows the imaging assembly 18 to bend to facilitate maneuverability ofthe feeding tube assembly 10. A second end, such as a proximal end, ofthe tubular housing 50 can be configured to receive the connectionportion 42 of the imaging assembly connector 20, and can be adheredthereto to secure the imaging assembly to feeding tube 12. The tubularhousing 50 may be generally opaque, by being formed from an opaque whitematerial or having an opaque material applied thereon, to reflectillumination from a light source, such as an internal LED 96, and directthe illumination outward from the distal end of the imaging assembly 18to, for example, a field of view.

The flex circuit assembly 60 typically includes a flex circuit 80 andelectronic components (not labeled), described below, attached thereto.In the partially assembled or folded configuration exemplarily shown inFIGS. 5, 7, and 8, the flex circuit assembly 60 can have a length with afirst longitudinal end, e.g., a distal end, and an opposite secondlongitudinal end, e.g., a proximal end. The electrical conductors 24 canbe connected to the second longitudinal end, e.g., the proximal end, ofthe flex circuit assembly 60. A camera mounting portion 82 is typicallydisposed at the first longitudinal end, e.g., the distal end of the flexcircuit assembly 60. An imaging device such as a digital camera,generally indicated at 84, can be mounted on the camera mounting portion82. The camera 84 can have a cuboidal shaped housing 86 with a base 86A,as shown in FIG. 8, sides 86B, 86C, 86D, 86E, and an upper or firstsurface 86F. The upper surface 86F of the camera 84 can include a lens88. The lens 88 defines a field of view that projects generally outwardfrom the distal end of the imaging assembly 18. In accordance with oneor more embodiments of the invention, the camera 84 comprises an imagingdevice, such as a CMOS imaging device. In further embodiments of theinvention, the camera 84 may comprise a different type of solid stateimaging device, such as a charge-coupled device (CCD), or another typeof imaging device. Other ways of configuring the electronics and othercomponents of the imaging assembly 18 do not depart from the scope ofthe present invention and may be implemented as variant embodimentsthereof. For example, in another embodiment, the flex circuit assembly60 may be replaced with a rigid printed circuit board (PCB).

The flex circuit assembly 60 can include a power mounting portion 90(FIGS. 5 and 7) and a control or data mounting portion 92 (FIG. 8) eachtypically extending from the camera mounting portion 82 at a fold linetoward the first longitudinal end of the flex circuit assembly 60. Aswill be described in further detail, power supply components aretypically disposed on the power mounting portion 90, and camera controlcomponents are typically disposed on the data mounting portion 92.

Referring to FIGS. 7 and 9, a light mounting portion 94 of the flexcircuit 60 can be disposed at the side 86C of the camera 84. The lightmounting portion 94 is illustratively depicted as extendinglongitudinally toward the camera 84 from a lateral side edge of the flexcircuit at a fold line of the power mounting portion 90. One or morelight sources 96 can be disposed on, for example, the light mountingportion 94 for illuminating an area or region adjacent to the uppersurface 86F of the camera housing 86. In the illustrated embodiment, thelight source is a light emitting diode (LED) 96 disposed on the lightmounting portion 94 so that the LED is disposed on the side 86C of thecamera housing and below or proximate the upper surface 86F of thecamera housing. In the illustrated embodiment, the LED 96 has a lightemitting surface 98 substantially perpendicular to the light mountingportion 94 for projecting light outward from the distal end of theimaging assembly 18. According to the illustrated embodiment (FIG. 9),the LED 96 and the light mounting portion 94 are positioned relative tothe camera 84 and the camera mounting portion 82 such that the lightemitting surface 98 of the LED 96 is a relatively short distance (e.g.,0.408 millimeters) below the upper surface 86F of the camera housing 86.Typically, LED 96 has an illumination zone that is at least partiallycoincident over an imaging zone or field of view of camera 84, throughoptional lens 88.

In another embodiment, one or more LEDs may be located distal of thecamera. As shown in FIG. 44, one example of flex circuit assembly isgenerally indicated at reference numeral 60′. As illustrated in a foldedor at least partially assembled configuration, a flex circuit 80′ of theflex circuit assembly 60′ can include an electrical component mountingportion 90′, a camera mounting portion 82′ on which a camera 84′ ismounted, and an LED mounting portion 94′ on which one or more lightsources, such as four illustrated LEDs 96′, can be mounted. The LEDmounting portion 94′ is typically configured to rest on an upper surfaceof the camera 84′ so that the LEDs 96′ are distal or offset from thecamera. The LED mounting portion 94′ can include an opening 95′ alignedwith the camera lens (not shown) so that the LED mounting portion 94′does not obstruct the field of view of the camera 84′. FIG. 45 shows theflex circuit 80′ in the unfolded or flat configuration. The flex circuitmay have other configurations and provide alternative locations formounting of the camera and the light source.

Referring to FIGS. 9 and 10, the camera 84 and the LED 96 areillustratively shown as disposed in the optically transparent cap 70.The cap 70 can be configured to diffuse light emitted from any of theone or more LEDs 96, and, in some cases, to filter the emitted lightinto a range of or a particular frequency. The cap 70 can have anexterior surface comprising a cylindrical attachment portion 100 that isconfigured to couple or mate with the distal end of the tubular housing50, and a dome-shaped portion 102 that may extend outward or projectfrom the tubular housing. In one example, the cylindrical attachmentportion 100 can be shaped and sized so that a snug fit is formed withthe interior surface of the tubular housing 50. A bonding agent may beused to further secure the cylindrical attachment portion 100 to thetubular housing 50. The connection between the cap 70 and the housing 50may be substantially waterproof to inhibit the ingress of liquid intothe imaging assembly 18.

In some embodiments in accordance with one or more aspects of theinvention, the cap 70 has an interior surface that defines a cavityextending inwardly from a proximal end of the cap. The cavity canprovide or define a camera receiving portion 104 and an LED receivingportion 106. The camera receiving portion 104 can be correspondinglysized and shaped to snugly or tightly receive the sides 86B, 86C, 86D,86E of the camera 84, and further can have a depth (indicated as “D” inFIG. 9) that is less than the height of the camera (indicated as “h” inFIG. 9) so that the camera extends out of the camera receiving portion104 at the proximal end of the cap 70. This snug fit of the camera 84 inthe camera receiving portion 104 inhibits movement of the camerarelative to the cap 70 and facilitates proper alignment of the cap 70with the camera 84. The position of the cap 70 relative to the camera 84may be adjusted or configured to at least partially reduce any effectsthat undesirably affects the quality of the image generated by theimaging assembly 18. In the exemplarily embodiment, the protrudingportion of the camera housing that extends outside of the camerareceiving portion can facilitate assembly by enabling the use of afixture for precise positioning of the camera and the cap. In othervariants, the cap may utilize different configuration to interface withthe housing or other components of the imaging assembly. For example,one or more variants embodiments may involve having circular cylindricalvolumes enclosing any of the one or more of the light sources and theimaging devices.

Referring further to FIG. 9, the interior of the cap 70 can be furtherconfigured to reduce unwanted light emitting from the LED 96 fromentering the camera 84 and being sensed or detected by the camera. Tominimize or at least partially reduce any reflection of undesirablelight into the camera 84, an interior camera-opposing surface 108 of thecap 70, opposing the upper surface 86F of the camera housing 86, can beoriented or constructed to be substantially parallel to the uppersurface 86F of the camera housing. Moreover, an interior light-opposingsurface 110 of the cap 70 opposing the light emitting surface 98 of theLED 96 can be disposed to be spaced longitudinally, i.e., distally, fromthe camera-opposing surface 108 of the cap. A relatively sharp angle,e.g., a right angle, may be implemented and defined by thecamera-opposing surface 108 and an interior surface 112 of the cap 70that connects the interior surface 110 to the interior surface 108. Thisconfiguration should reduce any undesirable internal reflection of lightemitted by the LED 96 into the camera 84.

Referring further to FIG. 10, the dome-shaped portion 102 of theexterior surface of the cap 70 includes central distal portion 116 thatcan be generally flat, e.g., generally planar. Side edges extending fromthe distal portion 116 to the base, e.g., proximal end of thedome-shaped portion, are round and generally smooth. Moreover, the baseof the cap 70 has a cross-sectional size and shape that can beapproximately the same as the cross-sectional size and shape of thehousing 50 so that the cap transitions smoothly to the housing. Overall,this general shape of cap 70 is referred to herein as a truncated-domeshape. The flat, central distal portion 116 should minimize or at leastreduce distortion in the field of view. In the illustrated embodiment,the flat, central distal portion 116 has a generally circularcircumference and an area that is the same size or larger than the fieldof view to further minimize distortion in the field of view. Moreover,the portion of the interior surface of the cap 70 that opposes the flatcentral portion 116 of the exterior surface (and the upper surface 86Fof the camera 84) can also be flat and can be substantially in parallelwith the flat central portion of the exterior surface, which shouldfurther minimize or at least reduce distortion in the field of view. Theround edges of the cap 70 can facilitate insertion of the distal portionof the feeding tube assembly 12 into the subject and promotes comfortduring intubation.

FIG. 11 shows an electrical block diagram directed to an exemplaryelectrical system 200 of the flex circuit assembly 60 in accordance withone or more embodiments of the invention. FIGS. 12 and 13 illustrativelyshow circuit diagrams of the exemplary electrical system 200. Theelectrical system 200 can include an electrical conductor connector 202,such as an insulation displacement connector, for receiving theelectrical conductors 24 from the outlet adaptor 20. According to theillustrated embodiment, the electrical conductors 24 include six signallines. The six signal lines in the illustrated embodiment include twopower supply lines (e.g., a power line, 5V, and a ground line, GND), twoserial communication lines (e.g., a serial clock line, SCL, and a serialdata line, SDA), and a differential pair (e.g., a low voltagedifferential signal positive line, LVDS_P, and a low voltagedifferential signal negative line, LVDS_N). The power supply lines (5Vand GND) are electrically connected to the LED 96 for energizing the LED96. In the illustrated circuit system 200, the power supply linesprovide 5 Volt power to a white light LED (e.g., part number LW QH8G orLW VH8G available from OSRAM Opto Semiconductor GmnH, Germany). Thepower supply lines (5V and GND) are also electrically connected to adual voltage regulator 204 (i.e., power supply) for providing powerthereto. The dual voltage regulator 204 generates two different voltagelines from the power provided by the power supply lines. In theillustrated circuit system 200, the dual voltage regulator 204 (e.g.,part number ISL9016IRUJCZ-T available from Intersil Corporation,Milpitas, Calif.) generates a 2.8 Volt power signal (e.g., analog supplyvoltage signal VAA) and a 1.8 Volt power signal (e.g., digital supplyvoltage signal VDD). The dual voltage regulator 204 is configured andelectrically connected to supply voltage generated therefrom to anoscillator 206, a serial communication device 208, and the camera 84. Inthe exemplary electrical system 200, the camera 84 can be part numberMTV9124M01, available from Aptina Imaging Corp., San Jose, Calif.However, other cameras or image sensors may be used without departingfrom the scope of the invention.

The oscillator 206, such as an 22 MHz oscillator, can be electricallyconnected to the camera 84 and configured to provide a timing signal(EXTCLK) thereto. The serial communication device 206, such as, an I2Cbus repeater, available from Philips Semiconducor or NXP B.V, Germany,is electrically connected to the two serial communication lines (SDA,SCL) and to the camera 84 for allowing data, i.e., non-image data, to becommunicated to and from the camera 84. For example, the serialcommunication lines (SDA, SCL) may be connected via the consoleconnector 22 to an external computing device. The external computingdevice receives data representative of one or more camera settings, suchas but not limited to resolution and frame rate. The camera settings canbe communicated to the camera 84 via the serial communication lines(SDA, SCL) and the serial communication device 208. The camera 84obtains images of the subject's anatomy in the field of view duringand/or following intubation thereof and generates imaging signals suchas a serialized digital video signal from the obtained images as afunction of the camera settings communicated via the serialcommunication device 208. Operations performed by the camera 84 aresynchronized as function of timing signal (EXTCLK) provided by theoscillator 206. The camera 84 outputs the signals, e.g., serializeddigital video signal, to the differential pair lines (LVDS_N, LVDS_P)for transmission to the console connector 22 and to the console 23. Theimages obtained by the camera 84 may then be delivered, processed, andviewed via the console 23.

FIG. 14 illustrates the flex circuit 80 in an unfolded, or flat (e.g.,planar), configuration. In the unfolded configuration, the cameramounting portion 82, the power mounting portion 90, the data mountingportion 92, and the light mounting portion 94 all lie generally in thesame plane and form a single planar surface (e.g., mounting face). Inone embodiment, all of the electrical components of the electricalsystem (e.g., electrical system 200) for the imaging assembly 18 areattached to a single, generally planar mounting surface 250 of the flexcircuit 80 when the flex circuit is in the unfolded configuration.Accordingly, the electrical components may be attached to the flexcircuit 80 while it is in the unfolded configuration to facilitatemanufacturing.

Relative locations of the electrical components of the exemplaryelectrical system 200 described above are shown in FIG. 14. Inparticular, the electrical conductor connector 202 (e.g., insulationdisplacement connector) and the power supply 204 (e.g., dual voltageregulator) can be attached to the mounting surface 250 of the powermounting portion 90. A configuration, such as the illustratedconfiguration, in which the power supply 204 is typically locatedrelatively close to the incoming electrical conductors 24, minimizes orreduces noise on the ground line (GND). The oscillator 206, e.g., timinggenerator, and the serial communication device 208, e.g., I²C busrepeater, can be attached to the mounting surface 250 of the datamounting portion 92. The camera 84 can be attached to the mountingsurface 250 of the camera mounting portion 82. The exemplarilyillustrated configuration locates the serial communication device 208further from the electrical conductor connector 202 than the camera 84because serial communication signals, e.g., serial data and serial clocksignals, communicated between the serial communication device 208 andthe electrical conductor connector 202 have a lower bandwidth than thevideo signal communicated from the camera 84 to the electrical conductorconnector 202. An LED 96 is attached to the light mounting portion 94.The camera mounting portion 82 is shaped and configured so that thelight mounting portion 94 can be disposed to be flush with a side 86C ofthe camera housing when the flex circuit assembly 60 is in the foldedconfiguration described above.

In one embodiment, the flex circuit 80 of flex circuit assembly 60 is atwo layer circuit. In particular, the flex circuit 80 includes a firstsubstrate and a second substrate, each having top and bottom surfaces.The first and second substrates may be composed of a flexible polyimidefilm. Electrically conductive material, e.g., copper, selectivelydisposed on the top surface of the first substrate forms a first circuitpattern, e.g. plurality of selectively connected traces. FIG. 15illustrates a first circuit pattern for the exemplary electrical system200 in accordance with some aspects of the invention. Electricallyconductive material selectively disposed on the top surface of thesecond substrate forms a second circuit pattern. The first and secondsubstrates are arranged in parallel with one another (e.g., stacked) sothat the top surface of the first substrate directly opposes the bottomsurface of the second substrate. The first circuit pattern and thesecond circuit pattern are electrically connected together by using, forexample, vias, and connected with the electrical components attached tothe flex circuit to form a two layer circuit. The flex circuit 80 may becomposed of other material and may be formed in other ways withoutdeparting from the scope of the present invention.

In one embodiment, the light mounting portion 94 of the flex circuit 80is configured to function as a heat sink. The electrically conductivematerial on the top surface of the first substrate and the electricallyconductive material on the top surface of the second substrate and canbe connected together using, for example, vias, to conduct heat from thefirst substrate to the second substrate. The traces formed on the secondsubstrate of the light mounting portion of the flex circuit can be widerrelative to traces formed on other portions of the first and secondsubstrates. For example, the wider traces may have a width of about0.008 inches. This configuration minimizes or can reduce the likelihoodof a temperature increase resulting from heat generated by the LED 96,and can allow a greater current to be provided to LED 96 to maximize orincrease the illumination capability generated by the LED 96, whilepreventing or reducing the likelihood of any damage to the LED 96 anddisturbances to the patient caused by undesirable or unacceptable hightemperatures.

Referring to FIGS. 7, 8, and 14, in order to convert the flex circuitassembly 60 from the flat configuration to the folded configuration, thepower mounting portion 90 and the data mounting portion 92 are foldedtoward each other at first fold lines 97 (FIGS. 7 and 8) to form thecamera mounting surface 82 between the fold lines 97. The power mountingportion 90 and the data mounting portion 92 can be folded a second timeat second fold lines 99 so that the two portions are generally paralleland in opposing relationship to one another. The light mounting portion94 also can be folded inwardly toward the camera mounting portion 82.

Alignment of the power mounting portion 90 and the data mounting portion92 during assembly can be facilitated because there would be nocomponents disposed on the inner or back surface of the flex circuit,i.e., the components are mounted on the mounting surface. The alignmentof the power mounting portion 90 and the data mounting portion 92 alsocan improve the alignment of the camera to a desired orientation. Thestresses and forces associated with the foldlines 97 and 99 on eitherside of the camera mounting surface 82 balance each other out. As aresult, the equivalent or counteracting stresses or forces inducespositioning the camera 84 into a particular orientation such that thelens 88 is aligned with the cap 70 and the viewing field of view of thelens 88 is can be coincident with the axis of the tubular housing 50.

FIG. 16 is a block diagram of an exemplary flex circuit electricalsystem according to an alternative embodiment of the invention. Asshown, the electrical conductors include four cables constituting foursignal lines. The four signal lines in the illustrated embodimentinclude two power supply lines (e.g., a power line, 5V, and a groundline, GND) and a differential pair (e.g., a low voltage differentialsignal positive line, LVDS_P, and a low voltage differential signalnegative line, LVDS_N). A microcontroller 210 cooperates with camera 84to allow integration into feeding tube assembly 10. The camera 84includes, for example, an I2C command/control interface and a serializeddigital video output interface. The microcontroller 210 can send commandand control signals directly to camera 84 rather than transmitting thesesignals over the length of the tube. Other operating parametersdescribed herein, such as the exemplary embodiments associated withFIGS. 11-13, may be implemented in this variant.

In FIG. 17, the electrical conductors 24 include four cablesconstituting four signal lines in accordance with one or more furtherembodiments of the invention. The camera 84 can be customized to operateautomatically and/or autonomously to a predefined operating protocolwhen powered up or energized. In this embodiment, camera 84 does not useor rely on external, incoming command/control signals. The operatingparameters of the camera 84, such as, but not limited to, exposure,white balance, can be pre-programmed, pre-set, or permanently set tocustom or tailored values for, for example, a particular or predefinedapplication. In one embodiment, for example, the custom values wouldtypically be stored in an associated memory structure. Camera 84 caninclude a sequencer (not shown), such as a microcontroller integrated inthe camera module itself, which has a one time programmable memory(OTPM) (not shown) that can be programmed with the custom values.Alternatively, camera 84 can include hardware registers (not shown) thathave the custom values stored therein, in which case the sequencer maybe optionally operable. Other operating parameters described herein maybe implemented in this embodiment.

FIG. 18 illustrates yet another embodiment of an exemplary flex circuitelectrical system. As shown in FIG. 18, the electrical conductors 24include two cables constituting two signal lines. The two signal linesin the illustrated embodiment include two power supply lines (e.g., apower line, 5V, and a ground line, GND) for supplying power from aconsole to the flex circuit 60. The console 23 can energize or providepower to the flex circuit 60 and can regulate voltage as needed to powera radio 212A as well as the camera 84 and other components of the flexcircuit 60. The camera 84 can then send imaging signals, such as videodata, via radio 212A wirelessly to a corresponding radio 212B located atthe console. In an alternative embodiment, the console 23 and the camera84 can communicate bi-directionally via radios 212A, 212B to exchange,for example, non-video data. Providing power to camera 84 in this mannercan eliminate the need for a limited-capacity energy source, such as abattery, in the camera module itself.

Reducing the number of signal lines as shown in FIGS. 16-18, especiallywhen combined with a flex circuit, may reduce cost and improvereliability and ease of assembly. And, fewer conductors reduce thelikelihood of inadvertently switching lines and incorrectly connectingthem during assembly.

Referring to FIGS. 2 and 4A, the exemplarily illustrated consoleconnector 22 includes a connector housing 228 and a printed circuitboard (PCB) 230, secured to the connector housing. The PCB 230 includesan edge connector 232 extending outward from the housing 228 so that anelectrical component mounting portion of the PCB is disposed in theconnector housing 228 and the edge connector is exposed and thus can begenerally accessible for a connection thereto. In the illustratedembodiment, the connector housing 228 defines a tube-connection opening234 in which the first and second tube segments 12 a, 12 b are secured,such as by an adhesive, to fluidly connect the first and second tubesegments. The tube-connection opening 234 may partially define thefeeding passage 14, or the feeding passage may be entirely defined bythe tube segments 12 a, 12 b. In one non-limiting example, a one-piecetube 12, incorporating or in lieu of segments 12 a and 12 b, extendsthrough the tube connection opening 234, such that the feeding passageis entirely defined by the tube and is not in fluid communication withany portion of the console connector 22. The tube 12 may be securedwithin the tube-connection opening 234, such as by adhesive. The consoleconnector may be of other configurations and may be secured to thefeeding tube assembly at other locations.

The electrical conductors 24 extend from the first tube segment 12 ainto the connector housing 228 and are electrically connected to the PCB230. An interface cable 242 (or other signal-transmitting component) canbe removably connectable to the edge connector 232 to effectcommunication and data exchange between the console 23 and the imagingassembly 18. As explained in more detail below, an electronic memorycomponent 243, such as electrically erasable programmable read-onlymemory (EEPROM), may be mounted on the PCB 230 to allow information(i.e., data) to be stored and/or written thereon and to be accessible bythe console 23 (i.e., a microprocessor 254 of the console 23) or anotherexternal device. It is understood that the PCB 230 may have additionalor different electrical components mounted thereon, or the PCB may beomitted such that the electrical conductors are operatively connected tothe PCB 230.

In another embodiment, a console connector may be formed on or securedto an inlet adaptor. Referring to FIG. 4B, in one embodiment of theinvention, a housing 228′ of a console connector 22′ is formedintegrally with an inlet adaptor 16′. The console connector housing 228′extends laterally outward from an outlet port 34′ of the inlet adaptor16′. Like the previous embodiment, the current console connector 22′optionally includes a PCB 230′ with an edge connector 232′ for use incommunicatively connecting the imaging assembly with the console. Anelectronic memory component, such as an EEPROM (not shown) may bemounted on the PCB 230′, as disclosed above and explained in more detailbelow. The feeding tube assembly may include a different type ofconnection for connecting the imaging assembly 18 to the console 23.

Referring to FIG. 3, the illustrated interface cable 242 includes firstand second interface connectors 244, 246 on opposite longitudinal endsof the cable. The first interface connector 244 is releasably mateablewith and electrically connectable to the edge connector 232, and thesecond interface connector 246 is releasably mateable with andelectrically connectable to the console 23. One or both of the interfaceconnectors 244, 246 may be discriminating connectors (i.e.,non-universal connectors) that will only mate and connect withrespective connectors associated with the feeding tube assembly 10 andthe console 23. Moreover, the edge connector 232 (or other connector)may be disposed within a socket having a shape that selectively anddiscriminatingly mates with a corresponding, e.g., complementarilyconfigured, first interface connector 244. The socket and the firstinterface connector 244 may include engagement structures, such as ribsor other components that provide a friction-fit between the connectorand the socket to inhibit inadvertent disconnection. The connectionbetween the interface cable 242 and the console connector 22 may be ofother configurations without departing from the scope of the presentinvention.

Referring still to FIG. 3, the interface cable 242 may include a controldevice, such as a button 248, to allow the user to record a still image,e.g., take a snapshot image, of real time video being displayed on theconsole 23. Actuating the button 248 or other control device sends asignal to the console 23 instructing the console to record imageinformation, e.g., a still image along with associated temporalinformation. In one example, the control device 248 can be proximate oron the first interface connector 244; for example, the control devicecan be closer to the first interface connector than the first interfaceconnector 246. In one or more exemplary embodiments of the invention,the control device can be provided on the first interface connector orwithin 12 inches of the first interface connector. The console 23 mayalso include a snapshot control function, e.g., an icon, button, orother actuation device that allows the user to take and record asnapshot image using the console, that can be optionally stored in amemory structure, and which may include ancillary information such asthe date and time. In some situations or embodiments it is envisionedthat during insertion of the feeding tube assembly 10 in the patient,the console 23 may be located at a distance that is not within reach ofthe user, such as a medical practitioner. Thus, although the images,e.g., video, may be viewable on the console 23, the user may not be ableto reach the console to perform additional operations or functions onthe console during insertion of the feeding tube assembly 10.Accordingly, by providing a control device 248 on the interface cable242, and more specifically, by providing a control device that isadjacent the first interface connector 244, the user can take and recorda snapshot image without having to reach for the console 23. Theinterface cable 242 may be of other configurations without departingfrom the scope of the present invention.

As shown in FIG. 3, the illustrated console 23 can include a consolehousing 250, a console display 252, such as an LCD or other electronicdisplay, secured to the housing, and a microprocessor 254 disposed inthe housing. In the illustrated embodiment, the microprocessor 254communicates with the imaging assembly 18 through the interface cable242 and the electrical conductors 24. The microprocessor 254 can beconfigured to receive the imaging signal or video signal transmitted bythe imaging assembly 18 and display real-time images associated with theimaging signal on the display. As disclosed in more detail below, themicroprocessor 254 can be optionally configured to display a graphicaluser interface on the console display 252, or a different display. Theconsole 23 can include one or more user input devices to allow the useror operator to communicate with the microprocessor 254 to performvarious operations using the console 23. The display 252 may be atouchscreen, such as a touchscreen LCD or other types of displays, whichalso functions as a user input device. In one embodiment, thetouchscreen allows the image to be enlarged or reduced by touching thescreen with two fingers and either moving apart to enlarge or bringingtogether to reduce the image size. Other user input devices, in additionto or in lieu of the touchscreen display 242, such as a mouse, akeyboard, a joystick, or other user input devices, may also be provided.Some other devices may include, without limitation, the ability toaccept and act on voice commands or upon gestures by the clinician.These latter input devices have the advantage of not requiring that onebe able to touch the console. Other ancillary components can be utilizedin the console 23, including, but not limited to power supply subsystemsand serial buses.

Referring to FIG. 4A, as disclosed above the console connector 22 on thefeeding tube assembly 10 may include an electronic memory component 243,such as an EEPROM, for storing and/or writing data thereon that isaccessible by the console 23 or other internal or external devicesassociated with the feeding tube assembly, such as the enteral feedingpump. One or more of the following types of information may be providedon or written to the electronic memory component in one or moreembodiments of the present invention.

In one non-limiting example, data relating to the feeding tube assembly10 may be written, stored, or otherwise incorporated into the electronicmemory component 243. For example, data indicating the lot code and/orthe item code, e.g., serial number, may be written to the electronicmemory component 243, and be retrievable by the console 23 as apredefined identifier. Moreover, a proprietary verification code may beincluded in the electronic memory component 243 to provide informationthat can facilitate verification to the console 23 that the feeding tubeassembly 10 is a valid feeding tube to be used with the console. Theconsole 23 may be configured, by, for example, executing instructions,to verify that the feeding tube assembly is an acceptable, proper,unexpired, or compatible feeding tube assembly before allowing operationor additional operation. Without proper validation, for example, theconsole 23 may inhibit images from displaying on the console if thefeeding tube assembly 10 does not have a valid information, such as anacceptable code or an acceptable predefined identifier. Also, dataindicating whether the feeding tube assembly 10 is sterilized may bewritten to the electronic memory component 243. Other informationrelating to the feeding tube assembly 10 may also be written to orotherwise incorporated in the electronic memory component 243. Theelectronic memory component may thus serve as a validation assembly orkey that would provide one or more predefined identifying information,e.g., a predefined identifier, that can be utilized by the consolebefore or during operation thereof.

In another non-limiting example, the data indicating time (i.e., timestamps) relating to the feeding tube assembly 10 may be written to theelectronic memory component 243. For example, the date of manufacture ofthe feeding tube assembly 10 may be written to electronic memorycomponent 243. When the feeding tube assembly 10 is connected to theconsole 23, such as by the interface cable 242, the console may read thedata indicating the date of manufacture. In one non-limiting example,the console 23 may use the date of manufacture to determine if thefeeding tube assembly 10 has exceeded its storage life. If the feedingtube assembly 10 has exceeded its predetermined storage life, theconsole 23 may be configured or execute programmed instructions thatperform at least one of initiate an alarm, communicate a messageindicating that the storage life is exceeded, and prevent viewing ofimages from the imaging assembly 18. In another example, upon connectionof the feeding tube assembly 10 with the console 23, the console may beprogrammed to write a start date of service or date of first use on theelectronic memory component 243. This start date can be used as areference to determine when the predefined usage life of the feedingtube assembly 10 has been exceeded or is about to expire. For example,after writing the start date to the electronic memory component 243, theconsole 23 may be configured to determine the usage duration or use lifeof the feeding tube assembly, and compare the elapsed usage durationwith an expiration date (and time) to determine the remaining usage lifeor whether the service life, usage time, or both, of the feeding tubeassembly will expire or has expired. Other variants may involveperiodically, continually, or continuously determining whether thecurrent date or usage date exceeds the expiration date. If the console23 determines that the usage life of the feeding tube assembly 10 hasexpired, then the console may be programmed to at least one of initiatean alarm, communicate a message indicating that the usage life isexpired, make a record on any recorded images, and prevent viewing ofimages from the imaging assembly 18. The cumulative use time may bedetermined by writing time stamps to the electronic memory component 243to determine the hours of actual use.

The console 23 may be configured to write other information to theelectronic memory component 243. For example, the console 23 may beprogrammed to write a serial number (or other identifier) associatedwith the console so that other consoles and other devices, such asenteral feeding pumps, can read the electronic memory component 243 anddetermine which console was used with the selected feeding tube assembly10. In another non-limiting example, the console can be configured towrite to the electronic memory component 243 patient specificinformation including, for example, the subject's (e.g., the patient's)name, the subject's identification code, and other information relatingto the patient, including but not limited to, the type of enteralproduct to be fed to the patient as well as the patient's feedingschedule, feeding duration, associated feeding settings, or otherhistorical information. The patient information may be written to theelectronic memory component 243 before the feeding tube assembly 10 isconnected to the console 23, and the console may be programmed to readthe patient information. Alternatively, the user may use the console 23to write the patient's information to the electronic memory component243. The patient's information may be encrypted to ensure patientconfidentiality.

In yet another non-limiting example, a placement-confirmation time stampor some other confirmation identifier may be written to the electronicmemory component 243 to indicate that the proper placement of thefeeding tube assembly 10 in the patient was confirmed. The console 23may be configured to write the time stamp to the electronic memorycomponent 243 when the user indicates to the console that the feedingtube assembly is properly located. For example, the user may press abutton or perform some other operation to confirm proper placement. Inaddition to a time stamp or other confirmation identifier, a username orother user identification can be written to the electronic memorycomponent 243.

FIGS. 19-31 illustrate one or more features relating to an exemplarygraphical user interface of the console. One or more of the featuresdescribed herein may be incorporated into various embodiments of theinvention. FIG. 19 is a flow chart illustrating the operations of thegraphical user interface when the console 23 is powered on for the veryfirst time, or when the console is activated after a predetermined timeperiod of non-use by a user. The predetermined period of non-use can beone month, six months, or even one year. Other triggering conditionsthat may affect a first time start may involve a loss of power.

As illustrated, a user interface screen prompts a user to indicatewhether the user is the very first user of the console 23 (hereinafter“initial user”), or whether the user has already been associated withthe console. If the user is the initial user, the console 23 grants theinitial user administrator status along with associated privileges foraccessing all or predetermined features of the console. Accordingly, at302, the initial user is prompted to select a language (labeled“Language”) that will be displayed on the user interface screens tocommunicate with users. At 304, the initial user is prompted to enterthe current date and time, and optionally to specify a format fordisplaying the time (labeled “Date/Time”). At 306, the initial user isoptionally prompted to enter time tracking options for display by theuser interface (labeled “Time Display”). The initial user can select oneof the following options: the current time of day is tracked anddisplayed by the console 23; the elapsed amount time for the currentprocedure being conducted by the feeding tube assembly 10 (e.g.,initiated when patient data is entered) is tracked and displayed by theconsole; both, the current time of day and the elapsed amount of timefor the current procedure being conducted are tracked and displayed bythe console. At 308, the initial user is optionally prompted to set upan administrator account by entering a username and a password.

If the user indicates that the user is not the very first user of theconsole 23, the console, at 310, presents to the user a log-in userinterface screen. The user enters a username and password. If the userenters a valid username and password associated therewith, the user islogged in. If the console 23 determines that the username and passwordare not valid, the console presents the user with a log-in retry (i.e.,message and another opportunity to log in). In one embodiment, after apredefined number of log-in attempts, the console 23 may be reset; allpatient data, user data, and device data may be deleted, locked orbecomes otherwise inaccessible. If the user is successfully logged in,at 312, the user is presented with a main selection user interfacescreen. The main selection user interface screen can present the userwith one or more of the following navigational options: utilityfunctions, procedure screen, file functions, and logout. Thenavigational options may be presented via text and/or graphical icons.In addition, a portion of the main selection user interface screen(labeled “Preview Video” or graphically represented as a movie reelicon, for example) is dedicated to providing the user with video data ifvideo data is being received from the imaging assembly 18 when the mainselection user interface screen is being accessed. As described below,this generally occurs when the user selects the main selection userinterface screen after initiating a procedure.

In one embodiment, the console 23 is configured to recognize a pluralityof classes (i.e., statuses) of users, and to limit operations that maybe performed by the console as a function of a class associated witheach user. For example, the console 23 may be configured to recognizefour classes of users: operators, administrators, approvers, andmaintainers. The console 23 can be configured to authorize the operatorclass of users to view video data that is received from the imagingassembly 18. The console 23 can be configured to authorize theadministrator class of users to create or establish user accounts orother operator accounts, along with respectively associated data storagesubstructures, and to view video data that is received from the imagingassembly 18. The console 23 is configured to authorize the approverclass of users to view video data or imaging data that is received fromthe imaging assembly 18 and to annotate approval data onto the videodata or imaging data received from the imaging assembly. The console 23can be configured to authorize the maintainer class of users to performmaintenance functions to the console such as software updates. However,the console 23 only authorizes the maintainer class of users to operatethe console if the console is not storing any patient data, e.g.,patient data must be deleted from console before a maintainer user isauthorized to operate the console.

If the user selects the utility functions from the main selection userinterface screen, a utility functions user interface screen can bepresented to the user. The options presented to the user on the utilityfunctions user interface screen are typically based on the class (i.e.,status) associated with the user. If the user is an operator or anapprover, the user can be presented with a utility functions userinterface screen. The console can then provide the user with the“Language” option and the “Preview Video” feature discussed above. Theutility functions user interface screen also can provide the user with a“User Manager” option which allows the user to navigate to a usermanager navigation user interface screen that allows the user to changehis/her password. If the user is an administrator, a utility functionsuser interface screen presented to the user has the “Language,”“Date/Time,” “Time Display,” and “Preview Video” options discussedabove. A “User Manager” option can also be provided, which allows theuser to navigate to a user manager user interface screen. A user manageruser interface for the administrator allows the administrator to add auser via the user interfaces. The utility functions user interfacescreen presented to the administrator also can also have an option,labeled “Reset/Erase Console,” for resetting (deleting patient data,user data, and device data) or erasing the console (deleting patientdata and device data) and for performing a software update, labeled “SWUpdate”. In addition to the options presented to an administrator user,the utility functions user interface screen presented to a maintaineruser additionally provides the maintainer user with the option toperform maintainer functions (labeled “Maintainer Functions”). Forexample, “Maintainer Functions” may include software debuggingfunctions.

Referring again to the main selection user interface screen if the userselects the “Procedure Screen” option, a patient information userinterface screen is displayed to the user via the console 23. Thepatient information user interface screen prompts the user to enter aname and identification for the patient for which the procedure is beingperformed. If the user enters the name and identification of thepatient, the procedure main user interface screen is displayed to theuser and the console 23 begins receiving video data from the imagingassembly 18 of the feeding tube assembly 10 so long as the feeding tubeassembly 10 is correctly connected to the console. If the user does notenter the name and identification of the patient, e.g., leaves thePatient Name and Patient ID fields blank, the user is presented with theblank patient information user interface screen. The blank patientinformation user interface screen allows the user to select to proceedwithout the entering the patient information or to enter the patientinformation. If the user selects to enter the patient information, theuser can be re-directed to the patient information user interfacescreen. If the user selects to proceed without entering the patientinformation, the procedure main user interface screen is displayed tothe user and the console 23 begins receiving video data from the imagingassembly 18 of the feeding tube assembly so long as the feeding tubeassembly 10 is correctly connected to the console. If the feeding tubeassembly 10 is not connected or is incorrectly connected to the console,the user is presented with an error message.

In one embodiment, the patient information may be manually entered bythe user. In another embodiment, the console 23 may include a bar codescanner (not shown) for scanning the patient's bar code wrist band toobtain the patient information. In yet another embodiment, the patientinformation can be provided on the electronic memory component 243.After communicatively connecting the feeding tube assembly 10 to theconsole 23, the console may read and record the patient information fromthe electronic memory component 243. This embodiment may be combinedwith the bar code scanner embodiment and/or the manual-input embodimentto provide a cross-check for the patient to ensure that the correctmedical procedure (e.g., enteral feeding) is being provided to thecorrect patient.

As illustrated in FIGS. 20 and 21, alternative procedure main userinterface screens can display the video data or the rendered orprocessed imaging data being received by the console 23 from the imagingassembly 18. The procedure main user interface screen also can displayany of the current time (if selected by the user) at 350, the patientname and identification number (if entered by the user) at 352 and 354,respectively, and the time elapsed for the current procedure (ifselected by the user) at 356. The time elapsed for the current procedurebegins when the user enters the patient name and identification orselects to proceed without entering the patient name and identification.The procedure main user interface screen also includes an option (e.g.,icon or button with text) for taking a snapshot at 358. The snapshotoption 358 allows a user to select to store the current frame of thevideo data or the rendered imaging data collected by the console fromthe imaging assembly 18. Identifying information about the snapshot maybe automatically provided and/or entered by the user on the console forlater identification of the snapshot. As disclosed above, the interfacecable 242 may include a control device 248, which may be provided inaddition to or in lieu of the snapshot option 358 on the console 23. At360, the procedure main user interface screen provides the user with thefile functions option (labeled “File Functions” or illustrated as afolder icon) which allows the user to access files stored by theconsole. The “File Functions” option may also be accessed directly fromthe main selection user interface screen. Upon selecting the “FileFunctions” options from either the procedure main user interface screenof FIGS. 19A and 19B, for example, or the main selection user interfacescreen, the user is directed to the file functions user interfacescreen.

The file functions user interface screen presents a user with a list ofdirectories stored on the console, and also includes the “Preview Video”feature discussed above. Each directory represents the video data or therendered imaging data that is stored in connection with one particularfeeding tube assembly 10. In one embodiment, the console 23 can read aserial number or other unique identifier from the console connector 22.The serial number or other identifier may be specific to the feedingtube assembly 10 such that it distinguishes it from all other feedingtube assemblies. In the illustrated embodiment, the console connector 22includes the electronic memory component 243 that stores the identifierfor the feeding tube assembly 10. All of the data that is received fromthe feeding tube assembly 10 having a particular serial number or otheridentifier can be stored under a single directory in the console 23.Data that is received from a feeding tube assembly 10 having a differentserial number or other identifier can be stored under a differentdirectory.

A user may select a directory for viewing and/or editing from the filefunctions user interface screen. When the directory is selected from thefile functions user interface screen, the user is directed to the filefunctions directory selected user interface screen (alternativeembodiments illustrated in FIGS. 22 and 23). This user interfacepresents the list of files (e.g., image files) associated with theselected directory. The image files represent the images selected by theuser via the snapshot option. The user is able to select at least onefile from the image directory and export the file via the “Export”option 380, rename the file via the “Rename” option 382, delete the filevia the “Delete” option 384, and annotate or view the file via the“Annotate/View” option 386.

If the user selects the “Export” option 380 from the file functions userinterface screen, the raw/JPEG user interface screen (alternativeembodiments illustrated in FIGS. 24 and 25) is displayed. This userinterface presents the list of files associated with the previouslyselected directory and allows the user to select one or more files. Theuser interface allows the user to specify a particular console universalserial bus (USB) port at 390 through which the selected files will beexported. A suitable number of busses may be provided. In one embodimenttwo, stacked busses are provided. In another embodiment, the console 23may additionally or alternatively be configured to export the selectedfiles wirelessly to a receiving device and/or to export the selectedfiles to the receiving device via an Ethernet connection. At 392, theuser is also presented at 392 with the option to delete the selectedfiles from the console once the selected files have been exported. At394 and 396, respectively, the user is prompted to select whether toexport the file as an uncompressed file (e.g., raw file) or to exportthe file as a compressed file (e.g., JPEG file).

If the user selects the “Rename” option 382 from the file functions userinterface screen, a rename user interface screen is presented to theuser to allow the user to rename the file. In one embodiment the defaultformat of the file is DATE_SUD-SN_PT-NAME_PTID_TIME_SEQ#.img, wherein

-   -   DATE=the current date (e.g., yyymmdd) set to the console via the        “Date/Time” feature    -   SUD-SN=single use device serial number (e.g., the identifier        retrieved by the console 23 from the console connector 22)    -   PT-NAME=patient name as entered by the user via the patient        information user interface screen    -   PT-ID=patient identifier as entered by the user via the patient        information user interface screen    -   TIME=the current time (e.g., hhmmss) set to the console via the        “Date/Time” feature    -   SEQ#=the image number as received from the imaging assembly,        wherein the first image sent from the imaging assembly has an        image number of 1 and the image number for each image received        thereafter is incremented by one.

In one embodiment, the “Rename” option 382 allows the user to changeonly the SEQ# portion of the file name.

If the user selects the “Delete” option 384 from the file functions userinterface screen, the delete user interface screen is presented to theuser to allow the user to delete files. The delete user interface screencan provide the user with a list of the files included in the previouslyselected directory. The user can select one more files from thedirectory and then select the delete option (e.g., delete button/icon).When the user selects the delete option from the delete user interfacescreen, the user is prompted via the delete confirmation user interfacescreen, to confirm that the selected files should be deleted from theconsole. Once the user confirms that the selected files should bedeleted, the selected filed are deleted from the console.

If the user selects the “Annotate/View” option 386 from the filefunctions user interface screen, a view user interface screen as shownin the alternative embodiments of FIGS. 26 and 27 is displayed. The viewuser interface screen can display the image stored in the selected file.The view user interface screen also can provide the user with an“Annotate” option at 400 and a “Compare to Video” option at 402. If theuser selects the “Compare to Video” option at 402, the console 23presents a compare user interface screen to the user (alternativeembodiments illustrated in FIGS. 28 and 29). A first portion 404 of thecompare user interface screen displays the image stored in the selectedfile. A second portion 406 of the compare user interface screen candisplay video data or rendered imaging data currently being received bythe console from the imaging assembly 18. The images on both the firstand second portions 404, 406 can in one embodiment be zoomed or panned.By comparing a previously captured image illustrating prior tubeplacement within a patient to current video data illustrating currenttube placement within the patient, a user can determine whether the tubehas migrated within the patient. Additionally or alternatively, a usercan compare an image of a previously placed tube to current informationrepresentative of a current tube placement to facilitate assessment asto whether the tube currently appears to be placed appropriately. Itshould be noted that the first portion 404 and the second portion 406 ofthe compare user interface screen are illustrated as being horizontallyaligned; however, the first and second portions, 404 and 406 maybealternatively arranged with respect to one another (e.g., verticallyaligned), and may be modified by the user without departing from thescope of the invention.

The compare user interface screen provides the user with an “Annotate”option at 408 and a “Procedure Screen” option at 410. If the userselects the “Procedure Screen” option 410, the console redirects theuser to the patient information user interface screen described above.If the user selects the “Annotate” option 408 from the compare userinterface screen (FIGS. 28 and 29), or the “Annotate” option 400 fromthe view user interface screen (FIGS. 26 and 27), the console presentsthe user with an annotate user interface screen illustrated in thealternative embodiments of FIGS. 30 and 31. The annotate user interfacescreen presents the user with a “Text” option at 420, and “Line” optionat 422, and “Approve” option at 424, an “Undo” option at 426, and an“Undo All” option at 428.

If the user selects the “Text” option 422, the annotate user interfacescreen allows the user to indicate (e.g., touch, click, etc) the portionof the image being displayed on the annotate user interface screen wherethe user would like to place the center of the text. After receiving theuser input indicating the location of the text, the annotate userinterface screen displays additional options to the user. In particular,the annotate user interface screen provides the user with the option toselect text naming an anatomical structure from a text list ofanatomical structures. The annotate user interface also provides theuser with the option to add free-text to the image. If the user selectstext naming an anatomical structure from the text list, the selectedtext appears on the screen centered over the user-selected textlocation. If the user selects to add free-text to the image, theannotate user interface screen adds a keyboard to the annotate userinterface screen and allows the user to enter text accordingly. If thekeyboard on the annotate user interface screen covers the user-selectedtext location, the text entered by the user is moved upward until theuser finishes entering the text. Once the text entry has been completed,the entered text can be displayed on the screen centered over theuser-selected text location.

If the user selects the “Line” option 422 the annotate user interfacescreen allows the user to indicate (e.g., touch, click, etc) the portionof the image being displayed on the annotate user interface screen wherethe user would like to place a first end of a line segment. The user maythen indicate, e.g., via a drag and drop operation, where the second endof the line segment should be located on the annotate user interfacescreen. If the “Undo” option 426 is selected, the last unsaved annotateditem, e.g., text, line segment, is removed from the image. Thisoperation can be repeated until there are no unsaved annotated itemsremaining in the image. If the “Undo All” option 428 option is selected,all unsaved annotated items are removed from the image.

If the user selects the “Approve” option 424, the user can bere-directed to the approver user interface screen. The approver userinterface screen prompts a user to enter his/her username and password.Once the username and password are entered, the console attempts toauthenticate the user as being associated with approver status. If theuser is authenticated, a message, such as “Approved by USERNAME on DATEat TIME” is added to the image (e.g., upper left of image beneath thepatient identification information, wherein

-   -   USERNAME=the username of the current user as entered in the        approver user interface screen    -   DATE=the current date (e.g., yyymmdd) set to the console via the        “Date/Time” feature    -   TIME=the current time (e.g., hhmmss) set to the console via the        “Date/Time” feature

Once an approver user has indicated that he/she approves the placementof the tube, the patient is allowed to be provided with nutrients viathe feeding tube assembly 10. For example, the console may be configuredto provide a signal that allows operation of feeding pump.

The order of execution or performance of the operations in embodimentsof the invention illustrated and described herein is not essential,unless otherwise specified. That is, the operations may be performed inany order, unless otherwise specified, and embodiments of the inventionmay include additional or fewer operations than those disclosed herein.For example, it is contemplated that executing or performing aparticular operation before, contemporaneously with, or after anotheroperation is within the scope of aspects of the invention.

Embodiments of the invention may be implemented with computer-executableinstructions. The computer-executable instructions may be organized intoone or more computer-executable components or modules. Aspects of theinvention may be implemented with any number and organization of suchcomponents or modules. For example, aspects of the invention are notlimited to the specific computer-executable instructions or the specificcomponents or modules illustrated in the figures and described herein.Other embodiments of the invention may include differentcomputer-executable instructions or components having more or lessfunctionality than illustrated and described herein.

Referring to FIGS. 32A-42, another embodiment of the imaging feedingtube assembly is generally indicated at 510. This embodiment is similarto the various embodiments disclosed above, and like components areindicated by corresponding reference numerals plus 500. Referring toFIGS. 32A and 32B, the imaging feeding tube assembly 510 includes afeeding tube 512, a inlet adaptor, generally indicated at 516, adjacenta second longitudinal end (i.e., a proximal end) of the tube, an imagingassembly, generally indicated at 518, adjacent a first longitudinal end(i.e., a distal end) of the tube, and a console connector, generallyindicated at 522, secured to the tube intermediate the inlet adaptor 516and the imaging assembly 518. The imaging feeding tube assembly 510 maybe used with the console 23, or a different console or display, fordisplaying image(s) generated by the imaging assembly 518, as disclosedabove. The inlet adaptor 516 is analogous to the inlet adaptor 16, andtherefore, reference is made to the prior inlet adaptor for anexplanation of various features of the inlet adaptor 516. Unlessotherwise specified below, disclosures relating to the components of theprevious feeding tube assembly embodiment 10, set forth above herein,also apply to the components of the current feeding tube assemblyembodiment 512.

The tube 512 can be a one-piece tube. Referring to FIG. 33, electricalconductors 524 (broadly, a signal transmission component) extendlongitudinally along substantially the entire length of the tube 512from the imaging assembly 518 to the console connector 522. In theillustrated embodiment, there are six electrical cables 524 for poweringthe imaging assembly 518 and transmitting data between the console(e.g., console 23) and the imaging assembly, although there may be moreor less cables without departing from the scope of the presentinvention. In the illustrated embodiment the cables 524 are disposed inthree separate and distinct conductor passages 526. The cables 524 areprovided in pairs, with each pair being disposed within the sameconductor passage 526 in the tube wall. In one example, the cables 524and the tube 512 may be co-extruded so that the cables are embedded inthe tube wall. After co-extrusion, the cables 524 may be laser ablatedto remove the respective jackets and/or mechanically stripped to exposethe wires so that the cables can be electrically connected to theimaging assembly 518 and the console connector 522.

Referring to FIGS. 34-37, the imaging assembly 518 can include anelongate housing 550; a flex circuit assembly, generally indicated at560 (FIG. 35), including a camera 584 and a light source 596 mountedthereon and received in the housing; and a cap 570 attached to thecamera at a first longitudinal end, e.g., distal end, of the imagingassembly. In this embodiment, a flex circuit 580 of the flex circuitassembly 560 can be a rigid-flex circuit including one or more spaceapart rigid structures 561 mounted on the flex circuit which inhibitbending. The electrical components, such as those described above withrespect to the previous embodiment, are mounted on the rigid structures561. The rigid-flex circuit 560 is capable of bending at bendinglocations 581 between the rigid structures 561 such that the rigid-flexcircuit is capable of selectively deforming solely at the bendinglocations 581 along the length of the folded rigid-flex circuit. Thelight source 596 and the camera 584 are mounted on the same distalcamera mounting portion 582 of the rigid-flex circuit 560, which extendsgenerally transverse to the longitudinal axis of the imaging assembly518. In the illustrated embodiment, the camera mounting portion 582 canhave one of the rigid structures 561 mounted thereon, to which thecamera 584 and the light source 596 can be secured.

Electrical components for operating the imaging assembly 518 may besimilar or the same as the electrical components disclosed above foroperating the previous embodiment of the imaging assembly 18. Inaddition to those electrical components, the rigid-flex circuit 560includes decoupling capacitors, generally indicated at 598, forproviding a stable supply voltage with low noise to the camera 84. Inthe illustrated embodiment, the decoupling capacitors 598 are embeddedin the camera mounting portion 582 of the rigid-flex circuit 560 betweenlayers thereof. In this way, the decoupling capacitors 598 areimmediately adjacent the camera 584.

Referring to FIGS. 40 and 42, the cap 570 may be similar to the cap 70except that the cavity in the cap 570 is typically sized and shaped forreceiving the camera 584 only, without the camera and the LED 596 as inthe previous embodiment. In addition, referring to FIG. 40, the cap 570includes a plurality of radial locking ribs 589 received incorresponding radial locking grooves 600 formed on the interior surfaceof the housing 550. The engagement between the locking ribs 589 and thelocking grooves 600 inhibit longitudinal movement between the housing550 and the cap 570. The cap 570 may be of other configurations withoutdeparting from the scope of the present invention.

In one non-limiting example (FIG. 40), the housing 550 may be molded andinclude longitudinally spaced apart reinforcing structures 591 (i.e.,wall portions of housing 550 with increased thicknesses), and bendinglocations 593 (with wall thickness of housing 550 less that atstructures 591) disposed between the reinforcing structures. Thereinforcing structures 591 are typically disposed adjacent theelectronic components and the rigid structures on the rigid-flex circuit580, while the bending locations 593 are typically disposed adjacent thebending locations on the rigid-flex circuit. Through this configuration,the cap 550 further promotes bending of the imaging assembly 518 atselected locations along its length and inhibits bending at longitudinallocations where the electronic components are located. The difference inwall thickness of housing 550 with respect to structures 591 andlocations 593 can be less than about 25%, less than about 10%, or lessthan about 5%.

In another non-limiting example (FIG. 41), the housing 550 may be moldedover the cap 570, the rigid-flex circuit assembly 560, and the imagingassembly connector 520 to form an integral imaging assembly 518. Forexample, the cap 570, the rigid-flex circuit assembly 560, and theimaging assembly connector 520 may be placed in a fixture of anovermolding process, and then the housing 550 may be molded over thecomponents. The material for overmolding may comprise urethane or othermaterial. In yet another embodiment, the housing 550 may be pre-formedand the cap 570 and the imaging assembly connector 520 may be secured tothe respective ends of the housing, such as by solvent bonding or inother suitable ways.

Referring to FIGS. 32A, 32B, 38 and 39, as with the previous feedingtube assembly 10, the current feeding tube assembly 510 includes animaging assembly connector, generally indicated at 520. Like theprevious embodiment of the imaging assembly connector 20, the currentimaging assembly connector 520 defines a feeding passage outlet 540 thatis in fluid communication with the feeding passage 514 of the tube 512.In the illustrated embodiment, the first longitudinal end of the tube512 is received and secured in the feeding passage outlet 540 of theimaging assembly connector 520 to provide fluid communicationtherebetween. The outlet 540 is closed adjacent to prevent liquidnutrients from entering the imaging assembly 518. Thus, the imagingassembly 518 is not in fluid communication with the feeding passage 514.Instead, the feeding solution is dispensed laterally from the outlet 540and to the patient (only one such lateral opening is shown in FIGS. 32and 38).

Referring to FIGS. 38 and 39, a first longitudinal end (e.g., a distalend) of the imaging assembly connector 520 defines an alignment slot 521for receiving a proximal end of the rigid-flex circuit assembly 560. Thealignment slot 521 facilitates proper positioning of the rigid-flexcircuit assembly 560 relative to the imaging assembly connector 520. Theimaging assembly connector 520 may be of other configurations withoutdeparting from the scope of the present invention.

Referring to FIG. 42, the console connector 522 can be secured to thefeeding tube 512 and can extend laterally outward therefrom. The presentillustrated console connector 522 includes a housing 728, and a PCB 730,an inlet adaptor connector 800, and a feeding tube connector 802 securedto the housing. A connector, such as a USB port connector 532, may bemounted on the PCB 730 for communicatively connecting an interface cableto the PCB 730. In another embodiment, the PCB 730 may include an edgeconnector, as disclosed above with respect to the previous embodiment.An electronic memory component 743 may be mounted on the PCB 730. Thehousing 728 can define a socket 736 having a size and shape for mateablyreceiving an interface connector (not shown) having a corresponding sizeand shape. A connector cap 737 can be tethered to the housing 728 forselectively closing the socket 736 when it is not in use.

The housing 728 may be molded over the inlet adaptor connector 800 andthe feeding tube connector 802 to secure the connectors to the housing.The proximal end of the feeding tube 12 is secured within a connectionpassage 804 in the feeding tube connector 802. The inlet adaptorconnector 800 connects the inlet adaptor 516 to the console connector522 and defines a passage 806 that fluidly connects the inlet adaptor516 to the feeding tube 512. In another embodiment (not shown), theone-piece feeding tube 512 may pass through an opening in the consoleconnector 522 and connect directly to the inlet adaptor 516. The housing728 may be secured to the feeding tube 512 using adhesive or in otherways. The housing 728 may be secured to the inlet adaptor 516, morespecifically, to the distal end of the inlet adaptor so that the housingabuts the inlet adaptor. The console connector 522 may have otherconfigurations without departing from the scope of the presentinvention.

Referring to FIG. 43, another embodiment of an interface cable forconnecting the feeding tube assembly 10, 510 to the console 23 isindicated at 742. The interface cable 742 is similar to the interfacecable 242 of the previous embodiment. Like the previous interface ableembodiment 242, the present interface cable 742 can include first andsecond interface connectors 744, 746 on opposite ends of the cable. Theillustrated first interface connector 744 is sized and shaped to mate,e.g., to be selectively inserted into, the socket 736 of the consoleconnector 522 and to make connection with the USB port connector 532, oran edge connector or another connector associated with the consoleconnector. The first interface connector 744 includes annular ribs orbeads 770 that engage an interior surface of the socket 736 to form asubstantially liquid-tight seal therewith to prevent the ingress offluid into the socket. The second interface connector 746 is sized andshaped to mate, e.g., to be selectively inserted into, with acorresponding socket of the console 23 and to make connection with theconsole. The first and second interface connectors 744, 746 and thecorresponding sockets 736 can be configured so that the first interfaceconnector 744 is not mateable with the socket on the console 23 and thesecond interface connector 746 is not mateable with the socket 736 ofthe console connector 522. The interface cable 742 may be of otherconfigurations without departing from the scope of the presentinvention.

In the illustrated embodiment, first interface connector 744 can includean imaging signal buffer component 750 (e.g., an I²C buffer component)which drives imaging signals (e.g., I²C signals) between the imagingassembly 18, 518 and the console. By locating the imaging signal buffercomponent 750 in the first interface connector 744, the capacitance issplit approximately equally between the conductors 24, 524 (e.g., wiresin the cables) in the feeding tube assembly 10, 510 and the conductors(e.g., wires) in the interface cable 742. This configuration minimizesor reduces capacitance in any one segment of the system and maximizes orimproves the image signal integrity. Moreover, the first interfaceconnector 744 and the imaging signal buffer component 750 will bedesirably adjacent the feeding tube assembly 10, 510 because the consoleconnector 22, 522 is mateable only with the first interface connector,and not the second interface connector 746. The interface cable 742 maynot include an imaging signal buffer component 750 and may be of otherconfigurations without departing from the scope of the presentinvention.

When introducing elements of aspects of the invention or the embodimentsthereof, the articles “a,” “an,” “the,” and “said” are intended to meanthat there are one or more of the elements. The terms “comprising,”“including,” and “having” are intended to be inclusive and mean thatthere may be additional elements other than the listed elements.

Having described aspects of the invention in detail, it will be apparentthat modifications and variations are possible without departing fromthe scope of aspects of the invention as defined in the appended claims.As various changes could be made in the above constructions, products,and methods without departing from the scope of aspects of theinvention, it is intended that all matter contained in the abovedescription and shown in the accompanying drawings shall be interpretedas illustrative and not in a limiting sense.

1.-7. (canceled)
 8. A feeding tube assembly comprising: a flexiblefeeding tube having opposite first and second longitudinal ends, alongitudinal axis extending between the first and second longitudinalends, and a feeding passage defined therein extending along thelongitudinal axis between the first and second longitudinal ends; aninlet adaptor adjacent the second longitudinal end of the tube in fluidcommunication with the feeding passage, the inlet adaptor configured forfluid connection to a source of enteral feeding liquid to fluidlyconnect the source of enteral feeding liquid to the feeding passage; animaging assembly including an imaging device, the imaging assemblyconfigured for generating and transmitting imaging signals indicative ofimages of the alimentary canal of a subject, wherein the imagingassembly is secured to the tube adjacent the first longitudinal end ofthe tube and is sealed from the feeding passage to inhibit enteralfeeding liquid in the feeding passage from entering the imagingassembly; a feeding outlet proximate the imaging assembly and in fluidcommunication with the feeding passage for delivering enteral feedingliquid to the subject; and a console connector communicatively connectedto the imaging assembly, the console connector configured for use inconnecting to the imaging assembly to a console to allow transmission ofthe imaging signals to the console.
 9. The feeding tube assembly ofclaim 8, wherein the longitudinal axis of the tube passes through thefeeding passage.
 10. The feeding tube assembly of claim 9, furthercomprising a signal transmission component extending longitudinallyalong the tube from the imaging assembly to the console connector toprovide communication between the imaging assembly and the consoleconnector.
 11. The feeding tube assembly of claim 10, wherein the tubeincludes a tube wall having an interior surface defining the feedingpassage and an exterior surface defining the exterior surface of thetube, wherein the signal transmission component is received in a signaltransmission passage in the tube wall and sealed from the fluid passage.12. The feeding tube assembly of claim 11, wherein the signaltransmission component is embedded in the tube wall.
 13. The feedingtube assembly of claim 11, wherein the signal transmission componentcomprises a plurality of signal lines.
 14. The feeding tube assembly ofclaim 13, wherein the signal lines consist of a power supply line, aground line, and a pair of differential signal lines.
 15. The feedingtube assembly of claim 8, further comprising an imaging assemblyconnector interconnecting the feeding tube and the imaging assembly,wherein the imaging assembly connector defines the feeding outlet. 16.The feeding tube assembly of claim 15, wherein the imaging assemblyconnector is more rigid than the feeding tube.
 17. The feeding tubeassembly of claim 8, wherein the imaging assembly comprises a deformablecircuit element, wherein the imaging device and a light source aremounted on the deformable circuit element.
 18. The feeding tube assemblyof claim 17, wherein the deformable circuit element includes a planarlongitudinal portion extending parallel to the longitudinal axis of thefeeding tube, and a planar transverse portion extending transverse tothe longitudinal axis of the feeding tube, wherein the imaging deviceand the light source are mounted on the transverse portion of thedeformable circuit element.
 19. The feeding tube assembly of claim 17,wherein the deformable circuit element comprises a proximal end securedto the feeding tube, a distal end remote from the feeding tube, theproximal end and the distal end defining a longitudinal axis of thedeformable circuit element therebetween, a camera mounting surfaceoriented transversely to the longitudinal axis of the deformable circuitelement, a light source mounting surface oriented transversely to thelongitudinal axis of the deformable circuit element and to the cameramounting surface, wherein the imaging device is mounted on the cameramounting surface, and the light source is mounted on the light sourcemounting surface at a position that is distal from the imaging device.20. The feeding tube assembly of claim 17, wherein the deformablecircuit element has a proximal end adjacent the feeding tube, a distalend remote from the feeding tube, and a longitudinal axis extendingbetween the proximal and distal ends, wherein the deformable circuitelement includes a camera mounting portion, on which a camera ismounted, extending transverse to the longitudinal axis of the deformablecircuit element, and a light source mounting portion being laterallydisposed relative to the camera mounting portion, wherein the lightsource is mounted on the light source mounting portion such that thelight source is laterally disposed relative to the camera.
 21. Thefeeding tube assembly of claim 8, wherein the imaging assembly is sizedand shaped for nasogastric intubation.
 22. The feeding tube assembly ofclaim 8, wherein the console connector includes an electronic memorycomponent having feeding tube data relating to the feeding tube assemblywritten thereon, wherein the electronic memory component and the feedingtube data are accessible by an external microprocessor.
 23. The feedingtube assembly of claim 22, wherein the console connector includes aprinted circuit board (PCB) having an edge connector adapted to connectto an interface cable, wherein the electronic memory component ismounted on the PCB and electrically connected to the edge connector. 24.The feeding tube assembly of claim 22, wherein the feeding tube dataincludes a predefined identifier associated with the connector assemblythat distinguishes the feeding tube assembly from other feeding tubeassemblies.
 25. The feeding tube assembly of claim 23, wherein thefeeding tube data includes a date of manufacture of the feeding tubeassembly.
 26. The feeding tube assembly of claim 8, wherein the consoleconnector is intermediate the inlet adaptor and the imaging assembly.27. The feeding tube assembly of claim 26, wherein the console connectorextends laterally outward from the feeding tube.
 28. The feeding tubeassembly of claim 26, wherein the feeding passage passes through theconsole connector.
 29. The feeding tube assembly of claim 8, wherein theimaging assembly includes a rigid-flex circuit, wherein the imagingdevice is mounted on the rigid-flex circuit. 30.-76. (canceled)